Covid-19 provides an unexpected catalyst for digital solutions
By Mike Bonham, MD, PhD
Laboratory medicine, like all of healthcare, was disrupted almost overnight by the covid-19 pandemic. From the sudden demand for SARS-CoV-2 testing to the need to accommodate social-distancing policies, laboratory operations have experienced unprecedented change over the last several months. The field of pathology has been especially affected. Though surprising to some, the practice of pathology has remained largely unchanged over the past 150 years. Despite the digital transformation that has impacted almost every other aspect of healthcare, pathology has held onto its traditional practices that center around a pathologist reading patient biopsies affixed to glass slides under a microscope in a laboratory environment. However, the need for social distancing has made this practice, along with consultations and tumor boards, significantly more challenging. As a result, many laboratories have been struggling to maintain operations since the pandemic broke out. They’ve been forced to limit on-site work to just one or two pathologists at a time or even ship slides to pathologists’ homes. This shift to remote work has led labs to consider—or reconsider—adopting digital solutions. The momentum behind digital pathology has long been building, and the covid-19 pandemic is proving to be the latest, and perhaps most unanticipated, factor in accelerating its adoption.
A Technology Whose Time Has Come
Digital pathology, which captures high-resolution images of tissue specimens, enables pathologists to access and view cases on demand from any location and easily share them for a second opinion. This technology presents an obvious solution to help laboratories maintain operations during these times. In fact, labs that were already digital before the pandemic have been able to work almost uninterrupted since the outbreak. So why have only some labs been prepared to take advantage of this opportunity? To fully understand, we must look at four key factors that have shaped the evolution of digital pathology: scanners, storage, software, and regulatory considerations. For the first three, available technology long was a barrier to adoption. The first scanners used to create digitized images for pathology were clunky, with long processing times. Storing these images was expensive, and the earlier software solutions for viewing and managing them offered limited functionality. Only more recently did information technology develop to the point that it became feasible for laboratories to consider going digital, and it was at this point that the momentum behind digital pathology’s adoption really began to pick up. Scanners have reached the point where they can handle the case volume that enters the typical pathology lab. Storage has become more affordable and flexible with the rise of cloud computing. And software solutions now offer a robust set of features for viewing, annotating, sharing, and analyzing images, including artificial intelligence (AI) applications. From automating time-consuming, manual tasks and prioritizing cases to centralizing pathology data, these features are driving meaningful improvements in accuracy, efficiency, and quality, highlighting the value that digital pathology can deliver. Digital pathology was gaining a foothold and clearly benefiting laboratories before the onset of covid-19; however, the regulatory climate still posed a challenge in the quest for full adoption. Few solutions had approval for primary diagnosis, which meant that the options were limited for labs that wanted to integrate digital pathology as a key component of their routine workflows. In April 2020, after it became clear that laboratories would need a means of operating remotely during the pandemic and digital pathology was a solution, the FDA issued guidance aimed at expanding the availability of remote digital pathology devices.1 This guidance, combined with a waiver issued in late March by the Centers for Medicare and Medicaid Services (CMS) that removes the validation requirements for viewing cases remotely, makes it much easier for pathologists to use digital pathology solutions for the primary diagnosis of cases at home.2
Into the Future
Covid-19 has become the unexpected catalyst for laboratories to embrace digital pathology. Unlike ever before, a lab’s ability to operate is directly tied to its digital footprint. Meanwhile, the FDA’s guidance temporarily broke down the final barrier to digitization, giving laboratories the flexibility to choose the best solution for their environments, just as the CMS waiver addressed the need for remote work. Although as of now these regulatory relaxations are in effect only during the pandemic, it’s difficult to imagine that pathologists—who are realizing the benefits of working remotely—will not wish to continue to do so. Published studies have also come out validating the accuracy of using digital pathology in remote settings with multiple monitor types, indicating that pathologists can successfully work from home.3 This push for the adoption of digital pathology comes at a fitting time. Laboratories are facing a surge in case volume as patients begin returning for routine cancer screenings they had postponed at the beginning of the pandemic. In June 2020, more than a million laboratory samples were estimated to be awaiting diagnosis in the United Kingdom.4 This increase in volume is exacerbated by the fact that 97% of UK pathology departments don’t have enough lab staff to conduct the work. As a result, patients are being forced to wait longer than usual for results and treatment, potentially sacrificing outcomes. Digital pathology would not only help pathologists still working remotely to read cases at home but also enable them to quickly collaborate with other pathologists and gain workflow efficiencies. These are likely among the reasons why the NHS is restarting its work to implement digital pathology, which had been put on hold when covid-19 broke out.5 The NHS also recently announced that it is implementing AI-based cancer detection to further increase efficiency and improve diagnostic accuracy—both benefits that are independent from remote work and are translating to laboratories in the United States that are adopting digital pathology as well. As laboratories increasingly adopt digital pathology to enable remote operations while some of the regulatory barriers are temporarily lowered, they will soon realize that viewing cases on demand from any location is only one of the many advantages of going digital. They will come to see that digital solutions address broader challenges faced by the industry as the number of biopsies increases and the pathologist population declines. While the global pandemic will inevitably pass, the need for timely, accurate cancer diagnosis will always remain a critical priority. l
Mike Bonham, MD, PhD, is a physician scientist with a passion for providing leadership around the convergence of fast-moving advances in artificial intelligence, digitization, and informatics that will transform healthcare. Dr. Bonham currently serves as the chief medical officer at Proscia, a digital pathology software company, and has previously held roles at Driver and Genomic Health. Dr. Bonham completed a pathology residency and two pathology fellowships at University of California, San Francisco. References 1. Food and Drug Administration. Enforcement policy for remote digital pathology devices during the coronavirus disease 2019 (covid-19) public health emergency: guidance for industry, clinical laboratories, healthcare facilities, pathologists, and Food and Drug Administration staff. https://www.fda.gov/media/137307/download. Published April 2020. Accessed August 12, 2020. 2. Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA) laboratory guidance during covid-19 public health emergency. https://www.cms.gov/files/document/qso-20-21-clia.pdf-0. Published March 26, 2020. Accessed August 14, 2020. 3. Hanna MG, Reuter VE, Ardon O, et al. Validation of a digital pathology system including remote review during the COVID-19 pandemic. Mod Pathol. Epub. June 22, 2020; doi: 10.1038/s41379-020-0601-5. 4. Lintern S. NHS on life support: Patients face diagnosis delays as hospitals struggle with surge in screenings. The Independent. June 10, 2020. https://www.independent.co.uk/news/health/coronavirus-nhs-delays-cancer-pathology-screening-radiologists-a9554871.html. Accessed August 12, 2020. 5. NHS to press on with digital pathology work. PublicTechnology.net. July 13, 2020. https://www.publictechnology.net/articles/news/nhs-press-digital-pathology-work. Accessed August 12, 2020. Featured image: A pathologist uses the Concentriq digital pathology platform to examine a whole slide image of a biopsy.